Category: International Nanoregulation

We would like to thank those of you out in cyberland who have found our blog – now only 9 months old – and have been interested in what we have to say about the emerging issues in nanotechnology and the law.  We hope that you continue to follow us in the coming months.

Writing a legal analysis blog has been a challenge.  Because of our interests in cutting-edge legal issues, in particular toxic torts and biotechnology, we have especially enjoyed the challenge of relating nanotechnology to existing and evolving legal doctrines.

Our promise for 2011 is to step up the pace of our posts while still maintaining our commitment to accurate and high-quality legal analysis.  As always, we welcome your comments on the blog.

Nanotechnology is a new frontier in the law, and we look forward to being able to offer readers our thoughts and insights on how the law will meet the challenges it presents.

 Best wishes for the new year.

The U.S. National Nanotechnology Initiative (NNI) Strategic Plan Draft was posted at for public comment on November 1, 2010.  The NNI was launched in 2001 with 8 agencies and now consists of the nanotechnology-related activities of 25 agencies.  Fifteen of these agencies have R&D budgets related to nanotechnology.

In reflecting on the 10-year history of U.S. nanotechnology research and development, the NNI Draft highlights its work as having “established a thriving nanotechnology R&D environment, laid the crucial groundwork for developing commercial applications and scaling up production, and created demand for many new nanotechnology and manufacturing jobs in the near-term.”  (Draft, p. 1)  Looking to the future, the NNI notes that nanotechnology R&D is “far from full realization.”  (Draft, p. 2)  The goals of the NNI continue to be broad:  continued development of R&D; developing the technologies into products for commercial and consumer use; and developing the physical and human resources to achieve these goals.

Goal 4 of the Draft Strategic Plan is “Support responsible development of nanotechnology,” including the twin goals of understanding and managing the risks of the technologies.  Among the NNI participating agencies in 2010 are EPA, FDA, National Institutes of Health (NIH), and National Institute for Occupational Safety and Health (NIOSH).

The NNI Draft Strategic Plan focuses directly on the benefits of nanotechnology, rather than the risks.  But many of the participating agencies – and many more – need to be involved on the risk side of the proverbial risk-benefit analysis.  This is happening, as reported previously in posts on this blog ranging from FIFRA to TSCA to the FDCA.

 But equally important is the need for communication and coordination on both the benefits and risks of nanotechnology.  And that extends beyond governmental regulation to businesses and nongovernmental organizations (NGOs).

Aside from governmental action, various voluntary initiatives and partnerships have emerged.  A report out of the Woodrow Wilson  International Center for Scholars, “Voluntary Initiatives, Regulation, and Nanotechnology Oversight:  Charting a Path,” gives an overview of the initiatives – some publicly sponsored, some developed by business, and some representing joint business-NGO partnerships.  These initiatives have the common, though separate, goal of developing a strategy to oversee environmental, health, and safety risks raised by nanomaterials.  The report is available at

Three initiatives discussed in some detail in the report are:

 ●  “Nano Risk Framework,” jointly developed by duPont and the Environmental Defense Fund (EDF)

 ●  “Responsible Nano Code,” sponsored by stakeholders from the United Kingdom

 ●  “Nanoscale Materials Stewardship Program,” developed by EPA

 The report critically analyzes these specific initiatives – as well as others more generally – and concludes that they have a welcome role in the future of nanotechnology safety and health efforts.

The ideal world does not exist, of course.  But in this world, a strategy that incorporates the risks and benefits of these developing technologies and brings together as many varied interests as possible representing all affected parties, including the environment, is warranted.  It can provide needed checks and balances along the way.

Getty Images

Getty Images

The good news is that both the European Union and Australia are moving toward adopting definitions of “nanomaterials” that will be used for setting standards for and developing regulation of these substances.  The news that may give some people cause for thought is that the definitions are not identical.

 This post is an update to my original post on the subject and looks at two definitions.  Consider the following.

  The European Commission, in a draft recommendation currently available for public consultation, has defined “nanomaterial” as

 “a material that meets at least one of the following criteria:

– consists of particles, with one or more external dimensions in the size range 1 nm – 100 nm for more than 1% of their number size distribution;

– has internal or surface structures in one or more dimensions in the size range 1 nm – 100 nm;

– has a specific surface area by volume greater than 60 m²/cm³, excluding materials consisting of particles with a size lower than 1 nm.”  (Art. 2, Sec. 1)

 The European Commission’s draft also indicated that the definition will be used “as an overarching, broadly applicable reference term for any Union communication or legislation addressing nanomaterials.”  (Preamble, 12)  Moreover, the Commission has recommended that the definition be reviewed frequently and adjusted to reflect scientific advances.  (Preamble, 7)

The Australian government is using a different definition, however, in a new administrative process published by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS).  The procedure requires new chemical manufacturers and importers to notify NICNAS of their intent to manufacture or import nanoscale chemicals and defines “nanomaterials” as

 “industrial materials intentionally produced, manufactured, or engineered to have unique properties or specific composition at the nanoscale, that is a size range typically between 1 nm and 100 nm, and is either a nano-object (i.e. that is confined in one, two, or three dimensions at the nanoscale) or is structured (i.e. having an internal or surface structure at the nanoscale”

 Further, the Notes to the working definition add that “where size distribution shows 10% or more of a substance (based on number of particles) is at the nanoscale, NICNAS will consider this substance to be a nanomaterial for risk assessment purposes.”

 The different definitions raise several issues:

 ●  The difference between 1%, per the European Commission, and 10%, per Australia’s NICNAS, could mean that many more substances would fall within the definition under EU standards than under Australia’s standards.

 ●  In an increasingly global economy, should manufacturers of nanomaterials be required to meet separate standards based upon definitions that vary from government to government?  One answer to this question is, Why not?  Manufacturers of chemicals and other products are frequently asked to meet different standards around the world, where some countries may be quite stringent and others lenient.  The tobacco industry moved a large segment of its business to Asia in response to litigation and regulation in the U.S., hoping to take advantage of a different regulatory climate.  Conversely, however, varying regulatory standards for chemicals can create difficulties and confusion for manufacturers and importers.

 ●  Nanotechnology is not only new to regulation as a discrete category, but will also be regulated in the international arena in the first instance.  Wouldn’t consistency, at least in the definition of nanomaterials, best serve this process?

 ●  Nanotechnology is widely viewed as beneficial with broad potential across all sectors of modern life.  Consistent definitions of what constitutes nanomaterials would assist firms in making business decisions going forward.

 Perhaps different definitions are only a step along the way toward ultimate agreement and consistency in the global arena.  Let’s hope so.

 The European Commission draft is available at

 The NICNAS processes are available at